Iontophoretic drug delivery system, including method for activating same for attachment to patient

• US 5,797,867 A
• Filed: 09/27/1996
• Issued: 08/25/1998
• Est. Priority Date: 09/27/1996
• Status: Expired due to Term

• Current Assignee: Vyteris, Inc.
• Original Assignee: Becton, Dickinson & Co
• Inventors: Guerrera, Stephen K., Bernhard, Michael I.
• Primary Examiner(s): Bockelman, Mark
• Assistant Examiner(s): TAO, ELLEN
• Application Number:
  US08/722,816
• Time in Patent Office: 697 Days
• Field of Search: 604/20, 604/21, 607/153
• US Class Current: 604/20
• CPC Class Codes: A61N 1/0448 Drug reservoir
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428

Abstract

The user activated iontophoretic device of the present invention includes a disposable patch and a reusable controller. The patch contains an electrode assembly, an electrode reservoir and at least one drug reservoir. The patch is divided or otherwise separated into at least two portions, with one portion containing the electrode reservoir and the other containing the drug reservoir, which may include a medication in a dry form. The electrode reservoir and the drug reservoir are sealingly separated by a barrier, which can be manipulated to bring the reservoirs into fluid conducting contact with one another. A method of activating the device includes causing the two portions to rotate about a central axis relative to one another to manipulate the barrier and bring the reservoirs into fluid conducting contact with one another to at least partially hydrate one of the reservoirs. In this way, the device is suitable for use to deliver a drug which has limited stability in an aqueous solution.

Claims

1. A user activated iontophoretic device for use in delivering at least one medication through an applied area of a patient, such as the skin, mucus membrane and the like, comprising:

a first portion and a second portion, said first portion including an electrode assembly and an electrode reservoir and said second portion including a drug reservoir;

said electrode assembly including electrode means for driving a medication into the patient to be absorbed by the body of the patient;

said drug reservoir containing an active compound to be delivered to the applied area of the patient; and

barrier means for sealing said drug reservoir in said second portion and including a foil seal having a tab, with the foil seal being adhered along the peripheral edge of the drug reservoir and the tab being adhered to the first portion so that movement of said first portion relative to said second portion manipulates said barrier means and brings the electrode reservoir and the drug reservoir into fluid conducting contact with one another, whereby said reservoirs are sealingly separated from one another with the active compound contained in the drug reservoir being isolated from the electrode reservoir in the first portion prior to activation so that upon alignment of said reservoirs and manipulation of said barrier means, the electrode reservoir and the drug reservoir are brought into fluid conducting contact with one another so that said drug is dissolved in an aqueous solution contained in said electrode reservoir.

2. The user activated iontophoretic device as defined in claim 1, wherein said active compound is initially in a dry form, separated from the electrode reservoir with the barrier means sealing said drug reservoir in said second portion.

3. The user activated iontophoretic device as defined in claim 1, wherein the active compound is in a dry form and homogeneously distributed in a carrier material so that the active compound may be kept in a dry form, separated from the electrode reservoir.

4. The user activated iontophoretic device as defined in claim 1, wherein the electrode reservoir includes an electrolyte in the form of an electrically conductive gel.

5. The user activated iontophoretic device as defined in claim 1, wherein the active compound is selected from the group consisting of cell adhesion molecules, GPIIb/IIIa receptor antagonists for the treatment of various throinboembolic disorders.

6. The user activated iontophoretic device as defined in claim 1, wherein the adhering force adhering said tab to said first portion is greater than the adhering force adhering said foil seal to said second portion.

7. The user activated iontophoretic device as defined in claim 1, wherein said first portion includes a compartment for at least containing the electrode reservoir and said second portion includes a compartment for containing said drug reservoir with the compartments sealingly separated by said barrier means so that said active compound is otherwise isolated from the electrode reservoir and the device may be activated by manipulating said barrier means to bring the electrode reservoir and the drug reservoir into fluid conducting contact with one another.

8. The user activated iontophoretic device as defined in claim 1, further comprising at least one spacer for separating said first portion before activation and said second portion, with said spacer upon activation extending outwardly from either said first portion or said second portion and a corresponding recess formed in the other portion for accommodating said spacer.

9. A user activated iontophoretic device for use in delivering at least one medication through an applied area of a patient such as the skin, mucus membrane and the like, comprising:

a first portion and a second portion, said first portion including an electrode assembly and an electrode reservoir and said second portion including a drug reservoir;

at least one spacer for separating said first portion before activation and said second portion, with said spacer extending outwardly from either said first portion or said second portion and a corresponding recess formed in the other portion for accommodating said spacer upon activation;

said electrode assembly including electrode means for driving a medication into the patient to be absorbed by the body of the patient;

said drug reservoir containing an active compound to be delivered to the applied area of the patient; and

barrier means for sealing said drug reservoir in said second portion whereby said reservoirs are sealingly separated from one another with the active compound contained in the drug reservoir being isolated from the electrode reservoir in the first portion prior to activation so that upon alignment of said reservoirs and manipulation of said barrier means the electrode reservoir and the drug reservoir are brought into fluid conducting contact with one another so that said drug is dissolved in an aqueous solution contained in said electrode reservoir.

10. The user activated iontophoretic device as defined in claim 9, wherein said barrier means includes a foil seal having a tab, with the foil seal being adhered along the peripheral edge of the drug reservoir and the tab being adhered to the first portion so that movement of said first portion relative to said second portion manipulates said barrier means and brings the electrode reservoir and the drug reservoir into fluid conducting contact with one another.

11. The user activated iontophoretic device as defined in claim 10, wherein the adhering force adhering said tab to said first portion is greater than the adhering force adhering said foil seal to said second portion.

12. The user activated iontophoretic device as defined in claim 9, wherein said first portion includes a compartment for at least containing the electrode reservoir and said second portion includes a compartment for containing said drug reservoir with the compartments sealingly separated by said barrier means so that said active compound is otherwise isolated from the electrode reservoir and the device may be activated by manipulating said barrier means to bring the electrode reservoir and the drug reservoir into fluid conducting contact with one another.

13. The user activated iontophoretic device as defined in claim 9, wherein the electrode reservoir includes an electrolyte in the form of an electrically conductive gel.

14. The user activated iontophoretic device as defined in claim 9, wherein the active compound is selected from the group consisting of cell adhesion molecules, GPIIb/IIIa receptor antagonists for the treatment of various thromboembolic disorders.

15. The user activated iontophoretic device as defined in claim 9, wherein said active compound is initially in a dry form, separated from the electrode reservoir with the barrier means sealing said drug reservoir in said second portion.

16. A method of iontophoretically delivering at least one medication through an applied area of a patient such as the skin, mucus membrane or the like, comprising the steps of:

releasably fastening a controller to a disposable patch, with said patch including an upper portion and a lower portion;

rotating said upper portion about a central axis relative to said lower portion;

manipulating a barrier means sealingly separating at least one electrode reservoir contained in said upper portion and a drug reservoir contained in said lower portion, with said drug reservoir containing an active compound to be delivered to the patient and said active compound initially being in a dry state;

bringing the electrode reservoir of the upper portion into fluid conducting contact with the drug reservoir of the lower portion to at least partially hydrate one of said reservoirs and to form a combined reservoir, with the combined reservoir to be applied to an area of the patient to be treated; and

causing current to flow through the device into the applied area to drive the medication into the body of the patient.

17. The method of iontophoretically delivering at least one medication as defined in claim 16, wherein the step of bringing the two portions into contact with one another includes manipulating a seal at least partially releasably adhered to the lower portion.

18. The method of iontophoretically delivering at least one medication as defined in claim 16, further comprising the step of removing a release liner from said lower portion to expose said reservoirs for application to the skin of the patient.

19. A method of iontophoretically delivering at least one medication as defined in claim 16, wherein said step of bring said electrode reservoir and said drug reservoir into contact with one another includes hydrating said drug reservoir.

20. A method of iontophoretically delivering at least one medication as defined in claim 16, wherein during said step of said electrode reservoir and said drug reservoirs into fluid conducting contact the drug contained in said drug reservoir is dissolved into said electrode reservoir.